CN106455907A

CN106455907A - Fully integrated, disposable tissue visualization device

Info

Publication number: CN106455907A
Application number: CN201580008607.7A
Authority: CN
Inventors: 理查德·A·金茨勒; 理查德·H·沃什本; 理查德·T·布里甘蒂; 卡尔·德尔曼吉安; 安德鲁·戴维森
Original assignee: AXIS SURGICAL TECHNOLOGIES Inc
Current assignee: AXIS SURGICAL TECHNOLOGIES Inc; Trice Medical Inc
Priority date: 2014-01-13
Filing date: 2015-01-13
Publication date: 2017-02-22
Anticipated expiration: 2035-01-13
Also published as: US10398298B2; US9370295B2; US20150196193A1; US20190038122A1; CN106455907B; AU2015204444B2; AU2017272307A1; US9610007B2; US20170086666A1; AU2019253909A1; US20160296108A1; WO2015106288A1; EP3094231A1; EP3094231B1; AU2019253909B2; US10092176B2; AU2015204444A1; AU2017272307B2

Abstract

The present invention relates to a fully integrated sterilizable one time use disposable tissue visualization device and methods for using such devices. Preferred embodiments of the invention facilitate the visualization of an internal tissue site while causing a minimum of damage to the surrounding tissue. Further preferred embodiments may allow for the delivery of fluids and other treatment to an internal tissue site.

Description

Fully-integrated disposable tissue visualization gasifying device

Cross-Reference to Related Applications

The application is the U.S. Patent application part in No. 18 Application No. 14/308,167 submitted of in June, 2014 Continue, and compile the 119th article of e money according to United States Code No. 35 to require to enjoy in No. 13 Application No. 61/ submitted of in January, 2014 The priority of 926,578 U.S. Provisional Patent Application, above-mentioned patent application is incorporated herein.

Technical field

This application describes for the instrument of tissue visualization, the embodiment of method and system.

Background technology

Treatment for condition of illness in human body and two kinds of traditional surgery of diagnosis may cause the bright of agency tissue Aobvious damage.These operations typically require long otch, the stripping of a large amount of muscle, lasting tissue contracts, the denervation of tissue and blood Block.Operating room time that this operation may need some hours and afterwards due to surgical operation during disorganization cause Some week the postoperative recovery times.In some cases, these invasive surgicals cause than the wound leading to operative treatment The more serious permanent scar of pain and the pain of injury.

Tissue (such as muscular tissue) due to requiring minimum is dissected, and therefore, the development of percutaneous surgery is extensive in minimizing Multiple time and postoperative pain aspect are greatly improved.For example, due to need enter body in position and to crucial intermediary The danger of histologic lesion, therefore, Minimally Invasive Surgical Technology is expected for vertebra and neurosurgery application.Although micro-wound surgical operation Development is striding in correct direction, but is still required for developing further in terms of micro-wound surgical operation equipment and method.

The treatment (for example osteoarticular treatment) of internal tissue location typically requires the visualization of target internal tissue.So And, the suitable visualization of internal tissue location is probably expensive and during operational costs, such as when needing nuclear magnetic resonance, NMR (MRI) When.In addition, the imaging of other patterns may potentially damaging tissue position, lead to the diagnosis of difference and the recovery time of prolongation. Accordingly, it would be desirable to improve for internal tissue location visible apparatus and method.

Content of the invention

Embodiments of the invention are related to tissue visualization gasifying device, method and system.In certain embodiments, tissue visualization Gasifying device includes visible sensor and elongate body, and elongate body has proximally and distally.The size of the far-end of elongate body Can be designed as through minimally invasive human body otch.In certain embodiments, device is further comprising administering to visible sensor and elongated master The integrated control mechanism of at least one maneuverability in body far-end.Further embodiment is provided for using tissue correcting device correction The method of the internal object tissue of patient.

Disposable tissue visualization gasifying device that a preferred embodiment of the present invention is completely integrated, aseptic.This device Including handle and rigid elongate main body, elongate body in the near-end being connected to described handle and includes laterally inclined along longitudinal axis Extend between the far-end at oblique tip.Imageing sensor is arranged in the handle, and elongated optical element extends past probe, institute State optical element and there is far-end and the near-end with described visible sensor optical communication.

Controller provides on described handle, and it is described thin for axially moving between proximal location and remote location Long main body, in described proximal point, the proximal lateral of the described most advanced and sophisticated far-end in described optical element, in described remote location Place, the distal side of the described most advanced and sophisticated far-end in described optical element.

Electric wire can be integrally attached to handle, and has the free end with adapter, with the electrical connection that can discharge To external observation device.

The black box of handle, probe and electric wire can be sterilized and be packaged in single sterile chamber.This makes not Need extra number of assembling steps, sterile chamber just can the aseptic occasion in clinical practice be opened, by electric wire insertion compatibility External observation device, and start the operation on patient.

The far-end of elongate body can have lateral drift.Deflection can with respect to longitudinal axis first direction, and Electric wire can be connected on handle at the second direction with respect to longitudinal axis, and second direction with the side-play amount of first direction is About 180 °.This provides vision and/or touch feedback on far-end lateral drift direction.Elongate body proximal retraction makes optical element At least about 1 ° of far-end lateral drift, at least about 2 ° or 3 ° or 5 ° or more, to expand visual field in certain embodiments. In certain embodiments, elongate body is not by lateral inclination in far-end, but whole elongate body can physically bend, Curve in elongate body is provided.The curvature that this curve has is approximately at least 0 ° -5 °, 5 ° -10 °, 10 ° -20 °, 20 ° - 40 °, 40 ° -60 °, 60 ° -90 °, or it is more than 90 °.

Optical element can include at least one and typically multiple optic visualization optical fiber and distal lens.Optics unit Part can extraly include at least one and generally multiple lighting fiber.Optic visualization optical fiber, illumination optical optical fiber and thoroughly Mirror can be contained in tubular body (such as hypotube).

Optical element can have the external diameter spaced inwardly with elongate body inner surface radial direction, to limit extension elongate body The annular chamber of length.Chamber can be connected with the injection port on handle or suction ports, for example, be used for medium (such as flushing liquor Or activating agent) injection or be used for aspirating.

In one embodiment of the invention, device include the elongate body containing No. 14 pins (2.1mm external diameter) or Outer tubular main body containing sharp distal.Optics hypotube can axially movably be positioned in outer tubular main body so that optics Hypotube can move from remote location and proximal location, and in remote location, optics hypotube extends beyond tip, in near-end At position, tip exposes in distal side.In certain embodiments, optics hypotube can include distal lens, contain multicomponent The image guide of optical fiber and extra lighting fiber, all above-mentioned structures are contained in hypotube.Image guide can wrap Include any amount of appropriate members, such as 10,000 element (such as optical fiber), meanwhile hypotube can be any suitable Number, such as No. 18 hypotube.In certain embodiments, image guide can include at least 1,000 element, and at least 3, 000 element, at least 8,000 element, at least 10,000 element, at least 12,000 element, at least 15,000 element, At least 20,000 element, at least 30,000 element, or it is more than 30,000 element.Elongate body can include rinsing Chamber, the such as annular gap between the internal diameter of optics hypotube and outer tubular main body.This chamber can be used for treating medium (example As, normal saline, the liquid containing biotic components such as stem cell, syntholube or other flowable medias) note Enter.In certain embodiments, this chamber can be used for normal saline being delivered to tissue location or transmission other therapeutic agents, for example Somatomedin, antimicrobial molecule or anti-inflammatory molecular.In certain embodiments and as in description elsewhere described in, optics Hypotube can be located in elongate body with non-concentric.For example, the central axis of optics hypotube can be towards elongate body Side or opposite side biasing.Optics hypotube can be alignd with the bottom of elongate body to help the blunt of elongate body sharp distal Change.In addition, in certain embodiments and as in description elsewhere described in, the far-end of optics hypotube can be made to bend To expand visual field.Between optics hypotube and elongate body the difference of axis also will advantageously allow for when optics hypotube include curved During the far-end of song/deflection, optics hypotube has bigger vertical gap.

In certain embodiments, in description, this part or the visualization device describing elsewhere can be used for except pass The injection of the various image guiding outside section injection.For example it is sometimes necessary to drug injection is entered the pericardium around heart.Mesh Before, grope ground or complete this injection using expensive visualization device.As replacing application, can occur in pericardial effusion When using visualization device, pericardial effusion is the disease producing when excessive blood accumulates around heart.Doctor can use Pin enters pericardial space, and is discharged fluid from pericardium by being referred to as the operation of pericardiocentesises afterwards.However, it is also possible to make Discharge fluid after penetrating pericardium with some embodiments of tissue visualization gasifying device by using elongate body and complete this Business.At present, doctor guides this kind of work using imaging device (such as heart ultrasonic examination or fluoroscopic examination (X-ray)).

Elongate body is carried by proximal handle, and elongate body by cable or can be wirelessly connected to watch-dog (for example IPad or other display).Output video and/or view data can be by cable or wireless connection transmission.Proximal handle Including CCD or CMOS optical pickocff, for shooting static and/or video image.The imaging device of the present invention makes it possible to In the case of direct visualizztion, the far-end of elongate body is accurately positioned, for example intracapsular in joint.Imaging device provides and examines Disconnected function it is allowed to doctor or other people effectively diagnose wound and/or disease.In an embodiment, device can also allow for by Treatment medium is reliably transmitted in joint, meanwhile in doctor's office under local anesthesia, thus avoiding to possible The needs of other diagnosis operations that are more inaccurate and/or needing longer waiting time.

In certain embodiments, tissue visualization gasifying device includes：

Handle, including visible sensor, this visible sensor is configured to collect the image of internal tissue location；

At least one lens；

Including elongate body proximally and distally, this elongate body includes chamber and optics hypotube, this chamber be configured to by Fluid is delivered to tissue location；

Storage algorithm in the handle, this algorithm construction is the Optical Chromatic in correction internal tissue location image；

Far-end, it includes sharp deflection front end.

In some embodiments it is possible to by the image comparing shooting and known limiting pattern and generate be specific to every The aberration of correct visualization device of individual independent tissue and the algorithm of image fault and produce optical correction.In some embodiments In, optical correction can be unique for single tissue visualization gasifying device.In a particular embodiment, relevant group can be stored The extraneous information (for example, the X of lens centre, Y location, the unique features of image circle size and LED) of tissue visualization device is to carry For unified initial light level.Can determine the preceding feature of tissue visualization gasifying device and description during manufacture elsewhere The additional features of description, these features can be stored in computer storage, the such as read-only storage of electronics erasable and programmable program Device (EEPROM).In an embodiment, the entirety of handle and elongate body can be integrated unit.In certain embodiments, handle Also include shrinking controller, it is configured to shrink elongate body to expose the distal lens of optics hypotube.In some embodiments In, handle can also include female Luer, and it is constructed by chamber and directs fluid into internal tissue location.

In a particular embodiment, the method for optical correction comprises the following steps：

Tissue visualization gasifying device is focused on known limiting pattern；

The image of limiting pattern known to shooting；

The image of limiting pattern known to relatively and the reference data set corresponding to known limiting pattern；

Difference between image based on known limiting pattern and known limiting pattern produces algorithm, and algorithm construction is by The image reconstruction knowing limiting pattern is the parameter of known limiting pattern；

In tissue visualization gasifying device memory storage optical correction；And

Using optical correction to correct the image collected by organism optical device.In certain embodiments, the method is also wrapped Include and tissue visualization gasifying device is inserted tissue location and collects image.In certain embodiments, visual for tissue location Change system can include：Fully-integrated tissue visualization gasifying device, it includes handle, the imageing sensor in handle and has light Integrated Probe that is fine and rinsing chamber；It is configured to show the display of the image collected by image visual gasifying device；With for providing The cable of electrical connection between display and tissue visualization gasifying device.

In certain embodiments, aseptic, integrated, expendable disposable tissue visualization gasifying device can include：

Handle, it includes visible sensor；

Watch-dog, it is configured to display image；

Elongate body, it is remote at the tip of the near-end being connected to described handle and inclusion lateral deflection along longitudinal axis Extend between end,

Elongated optical element, it extends through described elongate body, and described optical element has far-end and visual with described Change the near-end of sensor optical connection；

Controller on described handle, it is described elongated for axially moving between proximal location and remote location Main body, in described proximal point, the proximal lateral of the described most advanced and sophisticated far-end in described optical element, and in described remote location Place, the distal side of the described most advanced and sophisticated far-end in described optical element；

Wherein, the far-end of described elongate body is configured to penetrate tissue along described longitudinal axis；And

Wherein, the far-end of described elongated optical element includes the observation axis from described longitudinal axis laterally deflection.

In an embodiment, described most advanced and sophisticated transversal displacement is the 50% of the external diameter of described elongate body.Described observation axle Line becomes 15 degree of angles with respect to described longitudinal axis.Described elongated optical element also includes visual field, and described visual field is included along institute State the visual field forward of longitudinal axis.In an embodiment, described visible sensor is wirelessly communicated with described watch-dog.Described handss Handle includes shell shaped.Described far-end lateral drift by axially movable control line.Described elongate body can include It is configured to antibiotic medicine is delivered to the chamber of internal tissue location.In an embodiment, tissue visualization gasifying device also includes rotation sensing Device, described turn-sensitive device is configured to determine the direction of rotation of described visualization device.Described turn-sensitive device and described monitoring Device communication is with rotating image so that patient's reference direction is always occurred from the top of screen.In an embodiment, described elongated master Body includes outer tubular main body, and wherein, described outer tubular main body is manufactured by thermo-sensitive material.

In certain embodiments, the method manufacturing tissue visualization gasifying device comprises the following steps：

With desired angle cutting reflecting material thus exposing angled surface；

The described angled surface of milling (mill) is reflected image until described angled surface structure；

Described tubular reflector material is inserted tubular body, described tubular body includes window；And

Position described tubular reflector material so that light is reflected through described window by described angled surface.

Brief description

Other features and advantages of the present invention from the present invention combining accompanying drawing described in detail below be made apparent from, its In：

Fig. 1 illustrates the embodiment of tissue visualization system.

Fig. 2A -2C illustrates the various embodiments of tissue visualization gasifying device.

Fig. 3 A-3B illustrates the zoom side sectional view of the tissue visualization gasifying device far-end embodiment shown in Fig. 2A.

Fig. 4 illustrates tissue visualization and the vertical view cutaway drawing of correcting device embodiment.

Fig. 5 illustrates the sectional view of the tubular portion of tissue visualization and correcting device.

Fig. 6 A-6C illustrates to remove the embodiment of the tissue visualization gasifying device of shell.

Fig. 7 illustrates the side sectional view of lens case embodiment shown in Fig. 6 A-6C.

Fig. 8 A-8B illustrates the image fixing with and without rotation image.

Fig. 9 A-9D illustrates the embodiment of the tissue visualization gasifying device including minute surface.

Specific embodiment

This part of the application or elsewhere disclosed embodiment are related to micro-wound tissue visualization and interventional systems (access system) and device.It is additionally provided in the method using this system in imaging applications, and be used for implementing the method Instrument.It will be appreciated that the present invention is not limited to the specific embodiment describing before the more detailed description present invention, because this A little embodiments can change.It is also understood that terms used herein specific embodiment for illustration only and be not intended to limit System, the scope of the present invention is only limited only by the accompanying claims.There is provided the place of numerical range it should be understood that this scope Higher extreme value and low extreme value between each intermediate value and any other specified value in prescribed limit or Intermediate value is all contained in the present invention.These small range of higher extreme value and low extreme value can be independently include this relatively In small range and be also included in the present invention, and limited by the ultimate value of exclusion concrete in prescribed limit.In regulation In the case of scope includes one or two ultimate values, the scope of one of included ultimate value of exclusion or two is still Old it is included in the invention.

Some scopes presented herein had term " about ", " about " and " approximate " before numerical value.Herein using these Term is supported to precise figure before term and this digital word that is close or being similar to before term with providing.Carried In the text going out, determine numeral whether close to or approximately concrete record numeral when, close to or the approximate number do not recorded Word can be to provide the numeral being essentially identical to specifically record numeral.

The all publications and patents recorded in this manual are incorporated herein, and seemingly point out that each is single Only publication or patent are specifically and individually to be incorporated by reference and to be incorporated herein, thus disclosure The method related to the content that publication is recorded and/or material with description.Quote any publication be for the applying date before The disclosure of this publication, and should not constitute the money recognizing that the present invention is not had due to prior inventions prior to these publications Lattice.In addition, the publication dates being provided may be different from the actual publication date, need individually to confirm the actual publication date.

It should be noted that as herein and used in appending claims, the " one " of singulative and " being somebody's turn to do " Including plural referents, unless clearly indicated in literary composition.It shall also be noted that claim can be write to exclude selectable portion Part.So, this statement is to record removing property term as using as this in " only ", " only " etc. with claim elements Or what use " negating " limited quotes basis.

Those skilled in the art understand when reading the disclosure, without departing under the scope of the present invention or spirit, herein Each separate embodiments of description and explaination have the independent feature being easy to from any other several embodiment or combination The component of character separation and feature.The side of record can be implemented according to any other possible order of the order recorded or logic Method.

In sum, the aspect of the present invention includes minimally invasive imaging and visualization system.In certain embodiments, the present invention Imaging system is minimally invasive so that this system can be introduced into the internal object position of patient through little otch, for example intervertebral disc or Person's osteoarthrosis capsule is nearby or internal vertebral location.

In certain embodiments, the imaging system of the present invention can include intervention device and elongate body.Intervention dress Put the tube of the inner passage that can be there is near-end, far-end and proximally extend to far-end.Similarly, elongate body tool Have proximally and distally, and be dimensioned to be slidably moved the inner passage through intervention device.

In a particular embodiment, the intervention device of the present invention is the elongated member with inner passage, this elongated member structure Make is to provide to enter through minimally invasive otch from external position to user's (for example, health care professional, such as surgeon) Enter internal object tissue location (for example, in the middle of vertebra or vertebral members or neighbouring position, for example, in intervertebral disc or Nearby, in intervertebral disc etc.) entrance.The intervention device of the present invention can be the sleeve pipe of retractor tube system, part etc..By It is elongate in the intervention device of the present invention, it is 1.5 times of its width or longer length that intervention device has, and is, for example, it 2 times of width or longer, including being 5 times or even 10 times of its width or longer, for example, be 20 times of its width, It is 30 times of its width, or longer.

In certain embodiments, wherein intervention device be configured to through mini-incision provide entrance, intervention device the longest (for example, the external diameter of tubulose intervention device, including the wall thickness of intervention device, wherein intervention device is at certain for cross section side dimension Can be port or sleeve pipe in the case of a little) can in some cases in the range of from 5mm to 50mm, for example from 10mm to 20mm.As for inner passage, the size of this passage can be designed as providing from external position to the one-tenth of internal object tissue location Passage as device.In certain embodiments, the longest cross sectional dimensions (for example, the internal diameter of tubulose intervention device) of inner passage Length can be in the scope from 5mm to 30mm, such as from 5mm to 25mm, including 5mm to 20mm, for example, 7mm to 18mm. Expectation in the case of, intervention device hard enough with keep with tissue (for example, muscle) mechanical separation, and can by appoint What convenient material manufacture.The material interested that intervention device can be manufactured includes but is not limited to：Metal (such as rustless steel With other medical metal materials), plastics etc..

The system of the present invention can also include thering is elongate body proximally and distally, the wherein size design of elongate body For being slidably moved through the inner passage of intervention device or directly pass through to organize and do not use extra intervention to fill Put.This part due to system is elongate, and it is 1.5 times or longer length of its width that this part has, e.g. 2 times of its width or longer, including being 5 times or even 10 times of its width or longer, for example, be the 20 of its width Times, it is 30 times of its width, or longer.When being designed as using in knee surgery, being designed and sized to of elongate body Enter kneed capsule.The far-end of at least device have 10mm or less (such as 8mm or less and include 7mm or Less) the longest cross sectional dimensions, the length that wherein the longest cross sectional dimensions have in certain embodiments is from 5mm to 10mm In the range of, such as 6mm to 9mm, and include 6mm to 8mm.Elongate body can be solid or include one or many Individual chamber is so that this elongate body can be considered conduit.Referred to using the traditional sense of term " conduit " and be configured to be inserted into Hollow in human body, flexible or semirigid pipe.According to expectation, the conduit of the present invention can include single chamber or two or More chambeies, such as chamber of three or more etc..According to specific embodiment, elongate body can be flexible or rigidity , and can be by any convenient material manufacture.

As described above, some embodiments of the present invention include visible sensor and illumination component.In certain embodiments, These visible sensors are positioned in the handle of device proximal end.This system can include one or many in device proximal end One or more illumination components between individual visible sensor and the far-end positioned at elongate body and/or near-end.Specifically real Apply in example, one or more visible sensors (this part or those sensors describing elsewhere in such as description) May be located at the far-end (for example in the far-end of elongate body) of device.In certain embodiments, one or more visualizations pass Sensor may be located at each position in elongate body, for example, elongate body away from the length of far-end approximate four/ At one, at the half or 3/4ths away from the length of far-end for the elongate body.In some embodiments it is possible to make visualization pass Sensor is miniaturized so that these sensors do not increase the external diameter of elongate body substantially.

Similarly, as illumination component, the embodiment of system includes wherein one or more illumination components and is located at elongated master Those systems of the far-end of body and/or near-end.The embodiment of system also includes one of illumination component and is located at elongate body Far-end and/or near-end and other illumination component are positioned at the far-end of intervention device and/or those systems of near-end.And, it is The embodiment of system includes that wherein one or more illumination components are located at the near-end of device and light is by waveguide (such as fibre bundle) Those systems propagated to the far-end of device.The longest cross sectional dimensions for elongate body are usually 20mm or less, 10mm or less, 6mm or less, such as 5mm or less, including 4mm or less, or even 3mm or less.

Elongate body preferably includes image taking waveguide, illuminating waveguide and the chamber for fluid flushing and suction.

In certain embodiments, micro visuable sensor have 20mm or less, 10mm or less, 5mm or The longest cross sectional dimensions (Diagonal Dimension etc.) of less or 3mm or less, sensor is permissible in some cases There are the longest cross sectional dimensions in the range of 2mm to 3mm.In certain embodiments, micro visuable sensor have for The sufficiently small cross-sectional area of desired use and also the sufficiently high matrix resolution of holding.In certain embodiments, miniature can Can have the longest cross sectional dimensions of 0.5mm depending on changing sensor.In certain embodiments, the longest cross sectional dimensions are approximately 0.1mm, 0.2mm, 0.3mm, 0.4mm or be more than 0.5mm.In certain embodiments, visible sensor can be in 1mm-2mm Between (such as 1.3mm), or between 0.5mm-1mm (such as 0.75mm).The example of smaller size of visible sensor Produced by Fujikura and Medigus.Some visible sensors can have 2mm × 2mm or less (such as 1.8mm × 1.8mm or less) cross-sectional area (that is, x-y size, be also known as encapsulate chip size), and also have 400 × 400 Or the matrix resolution of bigger (such as 640 × 480 or bigger).In some instances, visible sensor has 500mV/Lux-sec or the sensitivity of bigger (such as 700mV/Lux-sec or bigger, including 1000mV/Lux-sec), The sensitivity of sensor is 2000mV/Lux-sec or bigger in some instances, such as 3000mV/Lux-sec or more Greatly.In a particular embodiment, visible sensor interested is (for example photosensitive including the photosensitive part being connected to integrated circuit The array of element) those sensors, wherein, integrated circuit is configured to obtain and integrated signal and to the back-end from light-sensitive array Processor exports analog data.Visible sensor interested can be considered as image sensor integrated circuit, and includes mutually Mend metal-oxide semiconductor (MOS) (CMOS) sensor and charge coupled device (CCD) sensor.In certain embodiments, visualize Sensor can also include with respect to photosensitive part positioning lens with by image focusing on photosensitive part.

Visible sensor interested includes but is not limited to those come the prestige science and technology (OminVision that to take pride in Technologies) company, Sony, the sensor of Sai Pulasi quasiconductor (CypressSemiconductor) company. Visible sensor can be with part interested (for example, a proximal handle or slim-lined construction or both of the above) bodily form Become.In certain embodiments, when (one or more) visible sensor is integrated at member proximal end, this sensor is not Cannot remove from the remainder of part in the case of the structure of obvious damage part.So it is impossible to remainder from part On easily remove integrated and visualized sensor so that the remainder of visible sensor and part formed inter-related whole Body.As described above, in certain embodiments, (one or more) visible sensor may be located at elongate body far-end or Person is along on any position of elongate body.

Although can in the apparatus of the present using any convenient visible sensor, in some examples, Visible sensor can be cmos sensor.For example, cmos sensor can be Aptina cmos sensor, for example Aptina MT9V124.This cmos sensor can provide very little pixel, and has small package size plus low pressure Differential signal (LVDS).The cable that this cmos sensor allows attachment to display includes less conductor, therefore with other Selection is compared permission and is reduced cable cost.Other cmos sensors interested be can from bold and unconstrained prestige science and technology (California, Sunnyvale city) obtain OmniPixel series cmos sensor (include OmniPixel1, OmniPixel2, OmniPixel3, OmniPixel3-HS) and OmniBSI series cmos sensor.These sensors can be that front side-illuminated passes Sensor or back side illumination sensor.The side of these sensors is further described in one or more following United States Patent (USP) The disclosure of following United States Patent (USP)s is attached to herein by face by quoting：U.S. Patent number 7,388,242；7,368,772；7, 355,228；7,345,330；7,344,910；7,268,335；7,209,601；7,196,314；7,193,198；7,161, 130；With 7,154,137.

In certain embodiments, elongate body can also include or many extending at least substantially in the length of device Individual injection chamber, for example, this injection chamber is used for executing various difference in functionalitys.In certain embodiments, wash away (that is, rinsing) in expectation In the targeted tissue site of elongate body far-end and when removing excess fluid, elongate body can include rinsing chamber and suction Chamber.During use, rinse chamber be operably connected to device proximal end fluid source (for example, physiology be subjected to fluid, for example Normal saline), wherein, fluid source be configured under positive pressure (for example under the pressure in the range of the mercury column from 0 to 500mm) by fluid Introduce chamber so that fluid is conveyed and discharge from far-end along rinsing chamber.

Although the size rinsing chamber can be different, in certain embodiments, the longest cross sectional dimensions rinsing chamber exist In the range of 1mm to 3mm.During use, suction chamber is operably connected to negative pressure source (for example, the vacuum in device proximal end Source), wherein, negative pressure source be configured under positive pressure (for example under the pressure in the range of the mercury column from 50 to 600mm) by fluid from remote Chamber is rinsed in tissue location suction at end so that fluid removes from tissue location and arranges along the conveying of flushing chamber and proximally Go out, for example, enter waste liquid pool.Although the size of suction chamber can be different, in certain embodiments, the longest horizontal stroke of suction chamber Sectional dimension is from about 1mm to 10mm, about 1mm to 4mm, about 1mm to 3mm or less than in the range of 1mm.Or, Ke Yiti For single chamber, can complete to rinse through this chamber and/or aspirate.In an embodiment, product encapsulation can be included as controlling stream The single port plug of the device of body flowing.In a particular embodiment, plug or suitable valve can be directly integrated into device In.In a further embodiment, it is possible to use multiple ports or plug, such as two ports and two plugs, three ports With three plugs etc..In certain embodiments it is provided that three-way plug, therefore clinician can not be attached In the case of pipe and reconnect pipe, between injection and suction or between first fluid injection and second fluid injection " switching ".

In certain embodiments, the system of the present invention is used together with reference to controller, and wherein controller is configured to control and shines The illumination of bright element and/or the shooting (for example, as still image or video frequency output) of the image from visible sensor. This controller can be with using various different forms, including the combination of hardware, software and both of the above.Controller can be with respect to Elongate body and/or intervention device are physically placed to any convenient position, such as in the near-end of system.In some embodiments In, controller can be independent of system unit, and that is, elongate body is so that provide control unit interface to be provided separately from near-end handss Handle, or controller can be integrally formed with proximal handle.

Fig. 1 illustrates the embodiment for the visual system of internal tissue location 2.In certain embodiments, tissue visualization Change system 2 includes：Tissue visualization gasifying device 4 (will describe in further detail below), controller 6 and offer controller 6 and The cable 8 of electrical communication between tissue visualization gasifying device 4.

In certain embodiments, controller 6 includes having internal memory port (such as SD card groove 10) and camera buttons 12 Shell.Camera buttons 12 can be with activation system to collect and to store static state or dynamic image.Controller 6 can also include electricity Source button 14, patten transformation button 16 and brilliance control 18.Controller 6 can also be included for showing still image and/or regarding The display (such as screen 19) of frequency.

Activation pattern switching button 10 can make system change between different mode, such as operative model and consultation of doctors mould Formula, collects video and/or still image in operative model and is shown in real time on video screen 19, face in consultation of doctors pattern Bed doctor selectively can show on video screen 19 that the image of storage and video are used for analyzing.For example, when in operation mould In formula, system can show video or the image from visible sensor in real time.Mean that screen 19 can be in group in real time Knit the video showing when being detected by clinician inside position within this tissue location.Video and/or image can also be by System automatically preserve for a period of time after broadcasting again.For example, when in the pattern of consultation of doctors, screen 19 can be easily The concrete image or the video that obtain before display system are so that clinician can easily analyze collected image/number According to, and with patient, image data is discussed.In certain embodiments, clinician can by touch screen or other Suitable device glosses to image.

In certain embodiments, screen 19 can be suitable for making any kind of plane of delineation of image viewing, example As the screen on iPad, video camera, computer display, mobile phone or the display (example by head wearing eyelid retractor carrying As glasses or other head up displays).In certain embodiments, permissible by device and display are configured to radio communication Omit cable.

In some embodiments, it may be desirable to removing line and providing wireless communication connection between probe and watch-dog, And be also possible to carry out wireless communication connection with central medical record memorizer and/or assessment position.Local transmission (for example arrives doctor Treat the transmission of the watch-dog in suite) can be completed by LAN, for example, based on IEEE 802.11 WLAN standard " WiFi " network, Bluetooth Wireless Personal Area Networks network standard or low-power consumption ANT wireless protocols.Transceiving chip with mutually powered-down Road will be appreciated that in the art, and can be placed in the handle casing of visualization device 4, and this will beg for below By.

Other replacement as traditional WiFi or based on IEEE 801.11 LAN, according to for medical center medical treatment The IEEE 11073 device specification of device communication, based on the IEEE 802.15.4 standard for wireless personal area network ZIGBEE network has been used to from various medical treatment device gather information, including such as pulse oximeter, blood pressure monitor, pulse prison Control device, scale and blood glucose meter.Compared with existing IEEE 802.15.1 Bluetooth Wireless Personal Area Networks network, for example, ZIGBEE net Network provides the advantage run under low power requirements (so that ZIGBEE transceiver is integrally connected under battery supply Probe).However, the transmission range between each ZIGBEE transceiver is typically limited to not more than hundreds of foot.Therefore, this net Network is suitable to and medical treatment device on-scene communication, but cannot be used for the central control location outside scene.Therefore, it is desirable to hybrid system, The configuration of one or more wireless personal area network is for convenience of between probe and dependent monitor and probe and one Or the on-scene communication between multiple wireless relay module, wherein wireless relay module is configured to and the CSRC system outside scene (for example, by network connection or wireless wide area network (WWAN), for example example is based on global system for mobile communications (GSM) for system communication Or the mobile telephone data network of CDMA (CDMA) cellular network or related wireless data channel etc.).Suitably continue Electric module and system are respectively in entitled " Wireless Relay Module for Remote Monitoring Systems (for the wireless relay module of long distance control system) " (the U.S. Patent application No.13/006 proposing on January 14th, 2011, 769) and " Medical Device Wireless Network Architectures (armarium wireless network structure) " Described in the patent application of (in the U.S. Patent application No.13/006 of No. 14 propositions of in January, 2011,784), above-mentioned patent application It is incorporated by reference in present patent application.

Therefore, any probe described herein can be provided with interface circuit, this interface circuit include with emitter and/ Or the transceiver of one or more of receptor, emitter and/or receptor are respectively used to via wireless network and medical treatment set Dependent monitor in room sends and receives video image, still image and other possible signals, and wireless network is e.g. low Rate wireless personal area network or " LR-WPAN ", ZIGBEE network or other low-power personal area network are (for example low Power bluetooth, or other WiFi network existing or follow-up developments).

Can also select to provide one or more relay module in patient device.Each relay module include for from Interface circuit receipt signal in handle probe or dependent monitor or the first transmitting-receiving to this interface circuit transmission signal Device, and each relay module also includes outfan, such as internet connection or for via wireless wide area network (" WWAN ") second transceiver to access point wireless signal transmission or from this access point receipt signal.The conjunction that the present invention uses Suitable WWAN includes for example, based on global system for mobile communications (GSM) or CDMA (CDMA) cellular network or related nothing Line data channel) network, or with 2G, 3G, 3G long evolving system, 4G, International Telecommunication Union's Radiocommunication Sector (ITU-R) the related network of WiMAX cellular radio standard.In order to the health insurance in accordance with 1996 carries and accountability act (HIPAA) any applicable patient data privacy provision, via the wireless network of equipment oriented (facility-oriented) Communication with each of WWAN preferably uses such as SSL (SSL) agreement or Transport Layer Security (TLS) agreement peace Entirely carry out.

It is additionally provided in instrument used in enforcement subject methods, wherein this instrument includes said apparatus and/or as mentioned above The part of thematic system one or more.So, instrument can include the visualization device being contained in aseptic packaging With the cable for being connected to controller.Instrument is additionally included in miscellaneous part used in enforcement subject methods, for example, controls Device, seal wire, stylet etc..Desirably (for example together or separate) various parts can be packed.Preferably, in packaging Part is pre-pasteurized, and the more details relevant with the pre-sterilization of packaging can be that the U.S. submitting for 16th for 2 months is special 2013 Profit 8,584, finds in 853, this patent is incorporated by reference into this specification.

Except those noted above, theme instrument can also include implementing subject methods for the part using instrument Explanation.For implementing the explanation record of subject methods in suitable recording medium.For example, explanation can be printed on substrate On, such as paper or plastics etc..So, illustrate can as package insert the container of instrument or instrument part etc. Deng label in (that is, pretend passs with packaging or subpackage) that appearance is in the tool.In other embodiments, illustrate to deposit as electronics Storage data file presents and occurs on suitable computer-readable recording medium, for example, CD-ROM, disk etc..At it In his embodiment, practical illustration book occurs without in the tool, but provides for obtaining and froming the perspective of from remote source (for example passing through network) Bright mode.The example of this embodiment is the instrument of the network address illustrating and/or can downloading explanation including checking.? In the case that there is explanation, for obtaining the mode record of explanation in suitable substrate.

Interested is also configured to the program that the method according to the invention runs visualization device, wherein, program record In physical computer-readable media, for example, it is possible to any medium being readable by a computer and directly accessing.This medium bag Include but be not limited to：Magnetic storage medium, such as floppy disk, hard disk storage medium and tape；Optical storage media, such as CD-ROM；Electricity Storage medium, such as RAM and ROM；With the mixing of these species, such as magnetic optical storage medium.Those skilled in the art can hold Change places and understand, how manufacture the product including storage medium using any one in known computer-readable medium, its In this storage medium have for minimally invasive instruction is carried out according to the present invention.

In certain embodiments, the program of device is included for the instruction running assembly of the invention so that being held by program During row, the instruction that is performed lead to image device execution thus：Illuminate targeted tissue site, such as osteoarthrosis or osteoarthrosis A part；With one or more picture frame being illuminated targeted tissue site using visible sensor shooting.

The inclusion photosensitive part that visible sensor interested is attached to integrated circuit (for example converts light into as electronics Photoarray) those sensors.Integrated circuit is configurable to obtain signal and integrated signal from light-sensitive array And output image data, this view data can be transferred in turn and be configured to receiving data and display to the user that this data External display.The visible sensor of these embodiments can be considered as image sensor integrated circuit.

The integrated circuit of these sensors can include various types of function, including but not limited to：Image is believed Number process, storage and data is transferred to data transmission circuit of external position etc. from visible sensor.Micro visuable Sensor can also include the lenticular unit being made up of one or more lens positioning with respect to photosensitive part, by image Focus on photosensitive part.In the case of desired, one or more lens can occur in shell.Interested is miniature The particular type of visible sensor includes mending metal-oxide semiconductor (MOS) (CMOS) sensor and charge coupled device (CCD) passes Sensor.Sensor can have any convenient structure, including circular, square, rectangle etc..Visible sensor interested There are the different the longest cross sectional dimensions according to specific embodiment, in some instances, the longest cross sectional dimensions are (for example, directly Footpath) it is 10.0mm or less, such as 6.0mm or less, including 3.0mm or less.

Visible sensor interested can be front or back lighting sensor, and has sufficiently small chi Very little, meanwhile keep enough feature to be integrated in the handle of apparatus of the present invention, the proximal end of elongate body.Also one Described in individual or multiple following United States Patent (USP), the disclosure of following patent is incorporated into this by quoting by the aspect of these sensors Literary composition：U.S. Patent No. 7,388,242；7,368,772；7,355,228；7,345,330；7,344,910；7,268,335；7, 209,601；7,196,314；7,193,198；7,161,130 and 7,154,137.

According to desired, the far-end of elongate body is so structured that to be observed for front and/or side is observed.Real at other Apply in example, elongate body is so structured that the view data providing from front and side, for example, carrys out the subjectivity of self-waveguide far-end Examine the angle that axis becomes greater than about 2 ° or 5 ° or 10 ° or 15 ° or bigger with the longitudinal axis with respect to elongate body Extend, will be described in greater detail in the following.

According to concrete device embodiment, elongate body can include or not include at least partly extending along a length thereof Individual or multiple chambeies.When there is chamber, the diameter in chamber can be different and can be used for various different purposes, for example, rush Wash, aspirate, being electrically insulated (electric insulation of the conducting element such as such as electric wire), as mechanical guide etc., will below more Describe in detail.When there is chamber, this chamber can have different the longest cross sectional dimensions, and scope exists in some instances 0.5mm to 5.0mm, such as 1.0mm to 4.5mm, including 1.0mm to 4.0mm.According to expectation, chamber can have any convenient Shape of cross section, including but not limited to circular, square, rectangle, triangle, semicircle, trapezoidal, irregularly shaped etc..Can To provide these chambeies for various different functions, include flushing and/or suction chamber, description in further detail below.

In certain embodiments, device includes being configured to illuminating targeted tissue site and makes this position to visible sensor For visual one or more illumination component, for example as described above.Various types of light source conduct can be adopted Illumination component, if light source be dimensioned such that it is positioned at the far-end of elongate body or light is delivered to the remote of elongate body End.This light source can be integrated so that light source is configured to respect to this part with given part (such as elongate body), Light source component can not be removed from the remainder of part in the case of the structure of inconspicuous this part of infringement.So, these enforcements The integrated lighting element of example easily can not remove the remainder shape so that illumination component and part from the remainder of part Become inter-related entirety.Light source can be light emitting diode or light transmission component (such as optical fiber), LED configurations For sending the light of expectation wave-length coverage, light transmission component is configured to the light of expectation wave-length coverage from addition to elongate body far-end The position position of elongate body proximal end (for example, in handle) is transferred to the far-end of elongate body.

In the case that there is visible sensor, light source can include conducting element (such as electric wire or optical fiber or Fibre bundle), this conducting element extended the length of elongate body to provide light source from external position (such as outer control device) Power and control.

In the case of desired, light source can include diffuser element to provide the Uniform Illumination of targeted tissue site.Permissible Using any convenient diffuser element, including but not limited to translucent mask or layer (by any convenient trnaslucent materialss system Make), the light being wherein derived from light source passes through this translucent mask or layer and by this diffuse-reflectance.System includes two or many wherein In those embodiments of the present invention of individual illumination component, illumination component can send the light of phase co-wavelength or illumination component is permissible It is the different light source of spectrum, " spectrum different " means that the wavelength of the light that light source sends is not substantially overlapping, such as white light and infrared Light.In certain embodiments, the United States Patent (USP) Shen that number of patent application is 12/269,770 and 12/269,772 occurs in a device The please lighting structure described in (its disclosure is incorporated herein).

In certain embodiments, assembly of the invention can be included for respect to visualization element linear ground mobile device Distal end member linear mechanical actuator, the distal end member of device is e.g. around the end of tubular needle of visualization element." linearly Mobile " mean to move substantially along straight line path.As it is used herein, term " linear " is additionally included in non-rectilinear (for example Bending) movement in path.

In certain embodiments, give elongate body far-end and/or visualization element far-end navigability integrated Linkwork there is also in device." navigability " means for example by using being positioned at the controller of device proximal end, Intra-operative as desired manipulate visualization element, tissue actuator and/or the far-end of elongate body or make with The ability of upper-part orientation.In these embodiments, device includes making desired distal component such as institute's phase by proximal controller Steerable maneuverability mechanism (or being located at one or more element of the far-end of elongate body) as prestige.So, Term as used herein " navigability " refers to the mechanism providing a user with operating function, for example in the desired manner (for example By make subjectivity examine axis with respect to initial axis direction to the left, to the right, upwardly or downwardly deflection) change nyctitropic ability.

Operating function can be provided by various different mechanisms.The example of suitable mechanism includes but is not limited to by suitable The one or more axially movable wire drawing that manufactures of material (such as shape-memory material, music wire etc.) or push away silk, Pipe, plate, net or a combination thereof.For example, an active deflection mechanism includes providing in distal ports 1108 along outer tubular main body The axially spaced multiple transverse grooves in 1126 the first side.Distal ports 1108 inner and outer tubular main body 1126 relative with the first side Second side of (that is, differing 180 degree) is used as axially incompressible post, and meanwhile the first side can axially be compressed thus drawing Play the first side lateral drift upwards recessed.First side second, opposite, side can be completed by axially movable control line It is compressed axially (or elongation) to cause or to remove bending.The far-end of control electric wire can be fixed to outer in distal ports 1108 On tubular body 1126, it is preferably fixed to the far-end of distal ports 1108.Control that electric wire is proximally facing extends past outer tubular The length of main body 1126 reaches near-end declination control device.Handling controller, so that controlling electric wire proximally to shrink, will make laterally Groove folds, and shortens the axial length of the first side with respect to the second side, so that distal ports 1108 deflection.

In some instances, when the major part of operation handle is maintained at fixed position, the far-end of elongate body has fair Permitted the single additional capabilities that far-end independently rotates around its longitudinal axis, more details be discussed below.

The far-end subjectivity of the present invention examine the hinged extension of axis can with respect to subjectivity examine axis change such as at least about 5 °, 10 °, 25 ° or 35 °.Visualization element is so structured that and rotates the four corner making angle in probe axis around its axis Either side on all can use, fundamentally increased effective viewing angle, will be described in greater detail below.Interested Linkwork further describes in the PCT application announced, Publication No. WO 2009029639；WO 2008/094444；WO 2008/094439 and WO2008/094436；Above-mentioned application is incorporated herein.Concrete articulated structure interested exists Further describe below with reference to accompanying drawing.

In certain embodiments, assembly of the invention may further include irrigator and aspirator, this irrigator and taking out Haustorium is configured to rinse the part (lens of such as visible sensor) of internal object tissue device and/or device.So, such as Described in upper, elongate body can also include basic one or more chamber extending in the length of device, for example, be used for holding The various different functions of row.Expectation wherein wash away (that is, rinse) elongate body far-end targeted tissue site (for example, To remove tissue of excision etc. from this position) some embodiments in, elongate body can include rinsing chamber and suction chamber two Person.Therefore, tissue correcting device can include the flushing chamber extending axially through elongate body.During use, rinse chamber permissible It is operably connected to the fluid source (for example physiologically acceptable fluid, such as normal saline) in device proximal end, wherein flow Body source be configured to (for example, under the pressure in the range of 0psi to 60psi) under positive pressure introduce fluid into chamber so that fluid along Rinse chamber to be conveyed and flow out in far-end.Although the size rinsing chamber can be different, in certain embodiments, rinse chamber The longest cross sectional dimensions in the range of 0.5mm to 5mm, such as 0.5mm to 3mm, including 0.5mm to 1.5mm.

During use, suction chamber can be operatively attached to the negative pressure source (such as vacuum source) in device proximal end.To the greatest extent The size of pipe suction chamber can be different, but in certain embodiments, the longest cross sectional dimensions of suction chamber are 1mm to 7mm's In the range of, such as 1mm to 6mm, including 1mm to 5mm.In certain embodiments, aspirator includes port, the cross section of this port Long-pending be elongate body distal cross section amass 33% or more (such as 50% or more, including 66% or more).

In certain embodiments, negative pressure source is configured to (negative pressure for example in the range of 300 to 600mmHg, example under negative pressure As 550mmHg) fluid and/or tissue are sucked suction chamber so that fluid and/or tissue from the targeted tissue site in far-end Remove from tissue location and conveyed along suction chamber and flow out from far-end, for example, enter waste liquid pool.In some embodiments In, rinsing chamber and suction chamber can be detached chamber, but in other embodiments, pre-washing function and pumping function can be by lists Individual chamber completes.

In certain embodiments, device can include being operably connected to the control structure of elongate body near-end, for example Handle." being operably connected " means that a structure is associated with another structure and (for example, is mechanically connected, electrically connects, light connects Connect etc.).When there is control structure (such as handle), control structure is located at the proximal end of device.Handle can have any Convenient structure, for example, have the holding rod of one or more control knob, have hand-held gun of trigger etc., wherein, The example of suitable hand held structures is provided below.

In certain embodiments, when the major part of operation handle is maintained at fixed position, the far-end of elongate body around Its longitudinal axis is rotatable.So, when being connected to the handle of near-end of elongate body and being maintained at fixed position, elongated master At least far-end of body is rotatable to a certain extent.The angle rotating in given equipment can be different, can from 0 ° to In the range of 360 °, such as 0 ° to 270 °, including 0 ° to 180 °.

Such as this part in the description herein and elsewhere described in, in certain embodiments, device can be one Secondary property or reusable.So, assembly of the invention can be that entirety is reusable (for example, is multipurpose Device) or overall time (for example, all parts of device are special purposes in this case).In some examples In, device can be that overall (reposable) that can reuse (for example, can reuse in this case by all parts The number of times of limited quantity).Each part of device can be individually special purpose, limited number of time reusable or unlimited Reusable, lead to the whole device being made up of part or system to have different available parameters.

Such as this part in the description herein and elsewhere described in, in some embodiments it is possible to using any Convenient material or a combination thereof manufacture assembly of the invention, and material includes but is not limited to：Metal material, for example, tungsten, stainless Steel alloy, platinum or its alloy, titanium or its alloy, molybdenum or its alloy and nickel or its alloy etc.；Polymeric material, example As politef, polyimides, polyether-ether-ketone (PEEK) etc.；Pottery, such as aluminium oxide (for example, STEATITE^TMOxidation Aluminum, MAECOR^TMAluminium oxide) etc..In certain embodiments, it is possible to use the material of structural property and light guide property is provided Material.

About the imaging within joint capsule, method is included the far-end of the visualization element of the present invention with respect to destination organization Orientate observation relation as.Observation relation means in the remotely located 40mm in targeted tissue site interested, such as 10mm Interior, including in 5mm.Far-end the determining with respect to desired destination organization of finder can be completed using any convenient method Position, including the direct linear travel from percutaneous point of penetration to destination organization.By the far-end of imaging device and destination organization positioning After observation relation, by using illumination component and imaging sensor, destination organization is imaged to obtain view data.For example Watch-dog or other suitable media as display device are used, the view data that the method according to the invention is obtained with The form of image exports to user.In certain embodiments, image is still image, but in other embodiments, image is Video.

In an embodiment, internal object tissue location can vary considerably.Internal object tissue location interested includes But it is not limited to：Osteoarthrosis, cardiac position, vessel position, central nervous system position etc..In some cases, internal mesh Mark tissue location includes vertebrae tissue.Osteoarthrosis can include any kind of joint interested in human body, for example knee or Person takes on.In certain embodiments, internal tissue location position interested during can including general surgery, including abdomen organ And/or surrounding tissue.

The other application of this part in this paper description or the tissue visualization gasifying device describing elsewhere includes In general surgery, (peritoneoscope or other Minimally Invasive Surgerys) uses as assistant visualizing device.In some instances, Ke Nengxu Laparoscopic camera to be removed and process becomes invisible.However, in this application, the external diameter of device described herein is enough Little allow they be used for eliminating after removing camera system dusky.In such an embodiment, elongate body is no longer Rigidity, conversely, main body is flexible, and may be mounted in elongate resilient tubular body and utilize multiple operating mechanisms Any one of (such as one or two or three or more bracing wires) makes far-end deflection.In certain embodiments, should Device can include offset bend far-end (for example, Nitinol), and it stretches line etc. by the outer straight sleeve of contraction or inside can Optionally bend or stretch.

The general surgery describing except this part of this paper description and elsewhere and other application, described herein visual The embodiment of gasifying device can use in the application of ear, nose and larynx.For example, device described herein may be able to have in visualization Use in any diagnostic evaluation being worth.As a further example, device described herein can be also used for guiding or assesses Sinusitis for example, the treatment of the expansion of hole (such as maxillary sinus).

In some instances, subject apparatus and method can expect the internal object imaging of tissue to experimenter wherein And/or use in the various different application of infringement to surrounding tissue for the minimum while correction.Subject apparatus and method are very Apply in use, for example but be not limited to wherein to visualize and potentially process various types of tissue (bag Include but be not limited to soft tissue, cartilage, bone, ligament etc.) surgical operation.Additive method using imaging device is included in public affairs The number of opening is those methods described in 2008/0255563 U.S. Patent application.

In one embodiment, using imaging device the far-end of pin to be accurately located at the joint capsule of such as knee Interior.This makes it possible to reliably basis, treatment medium be injected in capsule.For this application, the external diameter of tubular body has little In the diameter of about 3mm, preferably less than about 2.5mm, in one embodiment, close to 2.1mm (No. 14).

Fig. 2A illustrates the embodiment of tissue visualization gasifying device 1100, and it includes elongate body 1102 and handle 1104.Elongated At least about 1.5 times longer than its width of the length of main body, at least about 2 times longer than its width, at least about 4 times longer than its width, than it At least about 10 times of width length, at least about 20 times longer than its width, at least about 30 times longer than its width, longer than its width at least about 50 Times, or 50 times more than width.The length of elongate body can be different, and in some instances, this length can be at least about 2cm, at least about 4cm, at least 6cm, at least 8cm, at least 10cm, at least 15cm, at least 20cm, at least 25cm, at least 50cm or Person is more than 50cm.Elongate body can have along whole length identical outer cross-sectional dimension (for example, diameter).Or, horizontal Diameter of section can be different along the length of elongate body.In certain embodiments, the external diameter of elongate body arrives close to 0.1mm 10mm, close to 0.5mm to 6mm, close to 1mm to 4mm, close to 1.5mm to 3mm, close to 2mm to 2.5mm, or close to 2.1mm. In certain embodiments, elongate body is that have No. 14 pins of 2.1mm external diameter and 1.6mm internal diameter.

In certain embodiments, and as description elsewhere described in, elongate body has near-end 1106 and far-end 1108.Terms used herein " near-end " refers to elongate body and (is for example organizing operation device in revisional operation closer to user Surgeon) that end, terms used herein " far-end " refer to use during elongate body closer to experimenter internal object That end of tissue.In some instances, elongate body is that have sufficiently rigid structure to be applied to elongated master in enough power So that far-end is pushed into tissue during the near-end of body.So, in these examples, elongate body is at least on any obvious degree It is not flexible or flexible.In certain embodiments, far-end 1108 can also include sharp point as shown in Figure 2 A End is so that far-end can penetrate tissue (such as joint capsule).In certain embodiments, far-end can be by through skin and subcutaneous Organize and be pushed into joint capsule from human external.

As shown in Figure 2 A, in an embodiment, handle can have circular " shell " shape, and it includes connecting shell top 1112 Seam 1110 with shell bottom 1114.In certain embodiments, shell top 1112 and shell bottom 1114 can be made into two workpiece And link together at seam 1110 afterwards.Circular shell shaped provide the user the handle of comfortable and human engineering with Grasp during use device.In certain embodiments and by be described in more detail after a while, handle can include being configured to Shoot the image taking controller (for example, button 1116) of desired image.In other embodiments, image taking controller is permissible Including switch, actuator or other suitable mechanisms.Handle 1104 can also include shrinking or extend elongate body 1102 The contraction controller 1118 of the part of (for example sharp pin).To see that reference picture 2B-2C and follow-up figure retouch in more detail State contraction controller.

In certain embodiments, controller 1116 can optionally activate the acquisition of image and/or video.Therefore, control Device 1116 processed it is so structured that optionally start video record, stop video record and/or during video record or The video record down periods shoot still image.In certain embodiments, this controller or other controllers can be closed/beat Open ultraviolet (UV) light source being used together with UV sensitive material (such as gel).For example, UV sensitive liquid can be defeated Deliver to destination organization (such as knee), after-applied UV liquid so that this liquid curing be solid or semisolid material.Permissible UV light is produced by standard LED (those devices that such as description describes elsewhere).(for example can illustrate via lighting fiber Those lighting fibers that book describes elsewhere) UV light is guided towards destination organization, retain some lighting fibers to shine simultaneously Bright destination organization is for imaging.

In an embodiment, handle can include Rule (luer) interface 1120, and it is configured to connect to our department in description Any fluid source (such as physiological saline solution) dividing or describing elsewhere.Female Luer 1120 can with extended elongated The chamber of the whole length of main body is in fluid communication, to allow fluid or medicament to be transported to tissue location.

Connection between handle 1104 and elongate body 1102 can include for handle 1104 being connected to elongate body 1102 Bushing 1122.In certain embodiments, bushing can be dismountable, thus allowing elongate body to pull down from handle.At it In his embodiment, elongate body can be permanently attached on handle via bushing to provide integrated package.

Handle can also include being configured to connect to the strain relief node 1124 of cable (not showing that in Fig. 2A).Strain Eliminate node 1124 to can be used for reducing the strain on the electric wire electrically connecting with handle.

In certain embodiments, tissue visualization gasifying device 1100 is configured to disposable black box.In some realities Apply in example, tissue visualization gasifying device 1100 is pre-pasteurized, therefore, integrated and pre-pasteurized combination allows tissue visualization gasifying device Once removing packaging can be to employ.Using afterwards, this device can be abandoned.Therefore, handle 1104, elongate body 1102 and Miscellaneous part (such as cable) can be an integrated unit.One integrated unit means that above-mentioned various pieces can connect It is connected together and be not intended to as a workpiece allow user to dismantle.In certain embodiments, the various pieces of integrated unit are not It is inseparable in the case of damaging one or more part.In certain embodiments, in description this part or its He is also used as the part of single integrated organization visualization device and is comprised and sterilize the display of local description.

Fig. 2 B illustrates the sectional view of the embodiment of tissue visualization gasifying device shown in Fig. 2A.As in fig. 2, group If tissue visualization device includes dry part, such as image taking trigger 1116, shrink controller 1118, Rule 1120, elongated Main body 1102, handle 1104, and bushing 1122 etc..

In certain embodiments, far-end 1108 can include deflection construction, and wherein, the far-end of elongate body is with respect to elongated The longitudinal axis of main body 1102 tilt.This deflection is most advanced and sophisticated preferably sharp, thus allowing front end to penetrate tissue position interested Put.The deflection tip embodiment of far-end 1108 is explained in more detail below by reference to Fig. 3 A-3B.In an embodiment, point End can pass through skin and its hetero-organization to reach internal tissue location.

See as in Fig. 3 A now, elongate body 1102 includes outer tubular main body 1126, and it can be to have sharp point The hypodermic needle (such as No. 14 pins) at end.Visualization element is the form of interior optics hypo (hypo) pipe 1128, and it is concentric Extend through outer tubular main body 1126.Optics hypotube can serve as the image of tissue location passing to visible sensor 1132 (Fig. 2 B), such as this part and those sensors describing elsewhere in this paper description.Handle 1104 can also wrap Include near-end lens case 1130, will be more fully described in figure 7 below.

Reference picture 2C and Fig. 3 A, as described above, in certain embodiments, handle can include shrinking controller 1118.Receive The outer tubular main body 1126 that contracting controller may be used to Fig. 3 A is shunk with respect to optics hypotube, thus allowing optics hypotube Extend beyond open front at far-end 1108 for the outer tubular main body.Referring to Fig. 3 B.In certain embodiments, using sharp far-end To penetrate tissue to be introduced into elongate body in target area.Once elongate body has arrived at target area (such as joint capsule Interior), then can be with using shrinking controller 1118 so that the sharp tip of far-end of visualization element is proximally shunk.Logical Cross and so that sharp tip is shunk, user can guide the far-end of the elongate body of rust in tissue location, without again Penetrate the danger of tissue.The contraction of sharp tip is particularly useful for particular organization position.For example, once sharp far-end Penetrate osteoarticular joint capsule, there is the danger penetrating joint capsule opposite end.Shunk by making sharp end, pass can be shot The image of condyle and inject medicine, and it is not concerned about damaging joint capsule again.

In certain embodiments, the edge of elongate body and side and tip are blunt, with when inserting elongate body It is unlikely to damage surrounding tissue.Because the integrated essence of device leads to tip to be exposed to internal body structure, therefore sharp side Edge is crucial from the passivation of axial end and side.Similarly, generally blunt sleeve pipe has provides the removable of entrance tissue The trocar removing, rear sleeve replaced by detached video camera hypotube.

In certain embodiments, make optics hypotube with respect to outer tubular body bias using the deflection geometry of far-end And complete to be passivated.And, the far-end of outer tubular main body can include reverse sharpening (reverse grind), due to sharp side The edge directly external diameter against optics hypotube, therefore this reverse sharpening protect this edge further.In certain embodiments, outer tube Shape main body can include the recess on outer tubular body or optics hypotube, and this recess will make the external diameter of optics hypotube Internal diameter biasing with respect to elongate body.

Reference picture 3B can see reverse sharpening or back slope feature.Outer tubular main body 1126 can have angular cut with Produce main inclined plane 1416, this is common to hypodermic needle tip.However, this leads to sharp far-end 1410, it is with outward The inwall of tubular body 1126 is spaced the distance of wall thickness.In the structure shown here, probe distal is advanced through tissue and can lead to tissue It is trapped in the space between remote front end 1410 and optics hypotube 1128 outer wall.

Therefore, reference picture 3B, outer tubular main body 1126 can extraly arrange opposite slope or conical surface 1418, its Radially-inwardly incline along distal direction, and in opposite direction with main inclined plane 1416.This makes the sharp front end of far-end 1410 lean on The inwall outer tubular main body 1126 is placed, thus eliminate or minimize leading to forward group by the far-end of sharp front end 1410 Knit the danger of infringement.When the retracted orientation shown in outer tubular main body 1126 is in Fig. 3 B thus when being passivated, sliding contact point 1408 ( It is discussed below) it is located at remote front end 1410.Optics hypotube 1128 combines anti-with respect to the lateral offset of outer tubular main body 1126 Jointly produce hurtless measure distal structure to inclined-plane 1418.

Fig. 3 A is shown similar to the enforcement of the far-end 1108 of elongate body 1102 that the embodiment described in Fig. 2A -2C is similar to Example.Elongate body 1102 can be in extended position (as shown in fig. 3) it is allowed to the sharpening forward ends 1410 of far-end 1108 penetrate this This part or the tissue interested describing elsewhere in civilian description.As described above, retraction that ought be shown in figure 3b When in position, elongate body unlikely further damaging tissue position.In addition, the sharply remote front end 1410 of elongate body 1108 Can have lateral drift with respect to the longitudinal axis of elongate body 1102, produce deflection front end 1130.In other embodiments, Front end can be straight.When having in the direction that the handle of the controller at top is in Fig. 2 B, can be in upwardly direction Deflection.Can be with respect at least about 1 degree of the axis deviation of elongate body, 3 degree, 7 degree, 12 degree, 15 degree or bigger.

Deflection front end 1130 gives to change the machinery of optics hypotube direction of observation (e.g., from about 5-6 degree).At some In embodiment, direction of observation may be located remotely from least about 3 degree of the central longitudinal axis 1112 of optics hypotube, at least about 6 degree, at least About 12 degree, at least about 15 degree, at least about 20 degree, at least about 30 degree, at least about 45 degree or be more than 45 degree.The broad angle of visual field can To be completed using lens, or if far-end off-axis, completed by spin fiber.Deflection front end can also be in the insertion phase Between more preferable directional performance is provided and limits " core (coring) " related to conventional needle geometry and (minimize core-skin (skin core) is dragged in the patient and potentially causing the chance of infection).

With continued reference to Fig. 3 A, the elongate body 1102 with the deflection distal ports 1108 having discussed can in near-end extremely Few about 65% is substantially linear, and in some embodiments, at least about the 80% of axial length is linear.Do not consider Deflection, elongate body 1102 can be characterized with central longitudinal axis 1104, and wherein distal ports 1108 are from this central longitudinal axis 1104 lateral run-outs.

In the described embodiment, far-end sharpening forward ends 1410 are located proximate to and center by the angle of distal ports 1108 deflection Longitudinal axis 1402 align.Therefore, the lateral shift 1406 being led to by the deflection in described embodiment is outside elongate body 1102 About the 50% of footpath.Lateral shift 1406 is generally no greater than elongate body 1102 external diameter substantially, and in many embodiments extremely Be less elongate body 1102 external diameter about 10%, sometimes at least the external diameter of elongate body 1102 about 25%.At this In bright some embodiments, lateral shift 1106 in the range of elongate body 1102 external diameter is from about 40% to about 60%, Sometimes in elongate body 1102 external diameter about between 45% and 55%.

Above-mentioned front-end architecture allows elongate body 1102 to pass through tissue along substantially linear axis, meanwhile laterally to incline Tiltedly insert (launch) optics hypotube.Because optics hypotube 1128 is substantially linear, and elongate body 1102 has There are deflection distal ports, therefore, produce between the remote edge and the inner surface of elongate body 1102 of optics hypotube 1128 and slide Dynamic contact point 1408.The lateral inclination of outer tubular main body 1126 makes optics hypotube 1128 in outer tubular body 1126 with respect to light Transverse curvature when sea of learning wave duct 1128 proximally withdraws.This result can also be pre- by arranging in the distal ports of optics hypotube If lateral drift part and combine the outer tubular main body of the distal ports 1408 with deflection or substantially linear completing.

As short discussion, the effect of above-mentioned geometry makes it possible to machinery and widens transverse field.Can be alternatively Or additionally widened using the optics that various optical lens systems well known in the art complete visual field.

Reference picture 3B, optics hypotube 1128 will make it possible to examine axis 1412 along subjectivity observes.According to optics hypo The distal optics of pipe, subjectivity is examined axis 1412 and is generally started at the angle vertical with distal end optical surface, and position On the typically center of rotation of taper visual field 1414.Optics or software can desirably be passed through by visual field 1414 Geometric modification is for example oval, rectangle or other shapes.

In addition to additive method, axle can also be examined by the central longitudinal axis 1404 and subjectivity that confirm elongate body 1102 Angle theta between line 1412 examines the lateral drift of axis 1412 to quantify subjectivity.Angle theta can at least about 1 °, extremely Few about 3 °, at least about 7 °, at least about 12 °, at least about 15 °, or bigger angle, but generally no greater than about 45 °, some In embodiment, at least about 3 °, or no more than about 8 ° or 10 °.

Visual field 1414 can be characterized with angle alpha, and this visual field depends primarily on distal optics 1136.Angle Alpha generally between about 45 ° and about 120 °, such as between about 55 ° and 85 °.In one embodiment, angle alpha Close to 70 °.

Reference picture 3B is understood, visual field alpha enables the lateral drift that subjectivity examines axis 1412 to pass through certain scope Observe so as to horizontal, meanwhile still allow for central longitudinal axis 1104 and destination organization certain point in visual field 1414 Place is intersecting.This makes it possible to visualize along central longitudinal axis in the dead ahead of tubular body, meanwhile allows angle of deviation The increase in the horizontal visual field of degree.Therefore, elongate body 1102 enables optical field of view around the rotation of central longitudinal axis 1404 Enough inswept certain slewing areas, this increases total visualization target size effectively.For example, there are 70 ° of visual fields and 5 ° of deflections Embodiment in, the rotation a full circle around central longitudinal axis 1404 being capable of inswept 152 ° of available field of view.

In certain embodiments, elongate body includes chamber 1138, and this chamber 1138 makes including medicine (such as anti-inflammatory agent, antibiosis Element, anesthetis or other drugs well known in the art) fluid transmit or be delivered to other tissue location intracapsular.? In some embodiments, as shown in fig. 3, chamber 1138 can include between optics hypotube 1128 and outer tubular main body 1126 Annular gap.

In certain embodiments, visualization element far-end can include construct for ease of internal tissue location imaging remote End lens 1136.Distal lens or any other lens may occur defect and deficiency during manufacture, lead to image fault. These distortions are unique possibly for single lens, and therefore in the situation of embodiment disclosed herein, these distortions may be right It is unique in single tissue visualization gasifying device.Therefore, in order to improve picture quality, the device 1100 shown in Fig. 2A can wrap Include the automated optical correction of unique algorithm form.In certain embodiments, this algorithm can be stored in the chip in handle 1004 Or in other suitable devices.

In certain embodiments, automated optical correction can be used for improving the image matter being produced by tissue visualization gasifying device Amount.The Abbe number (also referred to as abbe number or constringence) of transparent material is the material dispersion (folding related to refractive index Penetrate the variable of rate and wavelength) measurement, high abbe number represents low dispersion (low aberration).Expect low aberration to optimize image matter Amount, but reach low aberration and generally increase manufacturing cost.In certain embodiments, aforementioned software can be passed through in Clinical practice Algorithm corrects the aberration in tissue visualization device, and this allows the saving during manufacturing.For example, optical correction can allow to have The Visual Performance of the device of relatively inexpensive lens and the performance using the visualization device of more expensive lens with minimal defects Quite.

In an embodiment, in order to produce in the algorithm manufacturing point, distal optics focus on known limiting pattern.It Afterwards, computer can compare the image of shooting and known pattern and create and for shooting image to be redeveloped into true limiting pattern Algorithm.As described above, this algorithm can be stored in the chip in handle 1104 afterwards.

Fig. 1 describes as previously explained, and when handle 1104 is connected in the display 6 of clinical location, algorithm is used as aobvious The basis showing device 6 with correcting captured image, thus removing the aberration in optical system.Each single tissue visualization gasifying device To have unique aberration, therefore each handle carries the unique algorithm being designed as correcting this system.

Return Fig. 3 B, Fig. 3 B be also shown in sharp distal 1204 embodiment of the elongate body of punctured position closer to regard Figure.As described above, related to Fig. 2 C, shrink and control for making sharp deflection front end 1204 shrink thus observing interior tissue Prevent from during position damaging surrounding tissue further.

Fig. 4 illustrates the vertical view cutaway drawing of tissue visualization gasifying device 1100 embodiment.Handle 1104 includes illumination component 1134 With visible sensor support member 1136, will be described in greater detail in the following.Retouch elsewhere similar in this specification The illumination component stated or equipment, illumination component 1134 can extend along the length of elongate body, and transports light to elongated To allow the visualization of destination organization below main body and to internal tissue location.In certain embodiments, illumination component 1134 wraps Include (one or more) illumination fiber optic bundle.

Fig. 5 illustrates the sectional view of the tissue visualization device embodiment below elongate body 1200 length, this elongate body Similar to the elongate body shown in Fig. 2A-Fig. 4.In certain embodiments, optics hypotube 1204 can include image guiding Part 1202, at least one lighting fiber or fibre bundle 1210, injection chamber 1206 and outer tubular main body 1208.As art technology Personnel will be understood that, terms used herein " lighting fiber " includes lighting fiber or fibre bundle.As description elsewhere Description, lighting fiber or fibre bundle are so structured that transmission carries out visualizing the ripple of suitable light to illuminating destination organization Long；However, lighting fiber may be configured to ultra-violet light transmission to tissue location with UV curing sensitive material.For example, if A total of 14 lighting fibers or fibre bundle, then 7 be configured to transmit to visualize suitable light simultaneously other 7 may be right Just suitable in transmission UV.However, it is possible to use any suitable combination.For example, the overwhelming majority in lighting fiber or Half or can be ultraviolet light less than half.In a particular embodiment, the quantity of lighting fiber can be according to Fig. 5 Quantity increase or reduce.For example, it is possible to there be an optical fiber, at least two optical fiber, at least 5 optical fiber, at least 10 optical fiber, At least 14 optical fiber, at least 20 optical fiber, at least 25 optical fiber, at least 50 optical fiber or be more than 50 optical fiber.In some realities Apply in example, lighting fiber is so structured that and exports multiple wavelength that internal tissue location is imaged with suitable light.

Can select for various concrete applications by lighting fiber 1210 (can be at least 4,8,12 or more light Fibre or fibre bundle, and may be arranged to the loop configuration around the image guide 1202 shown in Fig. 5, will in detail below Description) wavelength of light that transmits.For example, it is possible to using the wavelength in ultraviolet ray range to allow the vision difference of organization type, Thus nervous tissue is distinguished with surrounding tissue and/or minimum visual nervous tissue.Blood vessel can have the first color (for example red) occurs, and meanwhile, nervous tissue can have the second color (for example blue) and occur.Wavelength can also be optimized To distinguish nervous tissue and muscle.

In other application, can by optical fiber 1210 propagate light (such as ultraviolet light or visible ray) with promote or The hardening (for example, by polymerization or crosslinking) of injection solution forms solid or semi-solid block in live body, wherein passes through Injection chamber 1206 provides solution or gel.This block can be tissue bulking device, coating or other structures element.

Other wavelength concrete applications include the wavelength being pre-selected is directed to the mesh with medicine or prodrug dipping Mark.Once by the wavelength transmission being pre-selected to target, medicine is just released, or precursor is converted into medicine, this medicine it After be released.Target can be block or the device of implantation, or the carrier intermediary of injection, such as liquid, gel, drop Any one or combination.

Ultraviolet light can include ultraviolet light A, long wave, or black light, referred to as " UVA " and have the wavelength of 400nm-315nm； Black light, referred to as " NUV " and there is the wavelength of 400nm-300nm；Ultraviolet B or middle wavelength, referred to as " UVB " and have The wavelength of 315nm-280nm；Middle ultraviolet light, referred to as " MUV " and there is the wavelength of 300nm-200nm；Ultraviolet light C, shortwave or Person is germicidal, referred to as " UVC " and have the wavelength of 280nm-100nm；Extreme ultraviolet light, referred to as " FUV " and there is 200nm- The wavelength of 122nm；Vacuum-ultraviolet light, referred to as " VUV " and there is the wavelength of 200nm-400nm；Low ultraviolet, referred to as " LUV " and There is the wavelength of 100nm-88nm；Super ultraviolet light, referred to as " SUV " and there is the wavelength of 150nm-10nm；With extreme ultraviolet light, Referred to as " EUV " and there is the wavelength of 121nm-10nm.In certain embodiments, conduit can include launching the element of visible ray. Visible ray can include the purple light with 380nm-450nm wavelength；There is the blue light of 450nm-475nm wavelength；Have The cyan light of 476nm-495nm wavelength；There is the green light of 495nm-570nm wavelength；There is the yellow of 570nm-590nm wavelength Light；There is the Fructus Citri tangerinae coloured light of 590nm-620nm wavelength；With the red light with 620nm-750nm wavelength.In certain embodiments, Conduit includes launching the element with the light of wavelength between about 300nm and 500nm.Specifically, conduit can include transmitting and has The element of the light (for example, there is the light of the wavelength between about 450-475nm) of the wavelength related to blue light.Wavelength selects letter Breath and feature and the other details related to infrared ray scope (infrared endoscopy) are in the patent No. 6,178,346 United States Patent (USP)；The United States Patent (USP) Shen of the U.S. Patent application of Publication No. 2005/0014995 and Publication No. 2005/0020914 Please eventually in find, each of above-mentioned document is incorporated by reference in its entirety.

In certain embodiments, the external diameter of optics hypotube can range from about 0.1mm to 3mm, about 0.5mm arrives 2.5mm, or about 1mm to 2mm.In certain embodiments, the external diameter of optics hypotube is about 1.27mm.In some embodiments In, the internal diameter of outer tubular main body can range from about 0.1mm to 10mm, about 0.2mm to 8mm, about 0.5mm to 6mm, about 1mm To 5mm, about 1.2mm to 4mm, or about 1.4mm to 3mm.In certain embodiments, the internal diameter of outer tubular main body 1208 is about 1.6mm.

In certain embodiments, image guide 1202 allows the figure by the visible sensor tissues observed in handle Picture.In a particular embodiment, image guide can be optical fiber or other suitable media to allow by this paper description This part or the visible sensor describing elsewhere are imaged to tissue location.According to expected performance, fibre bundle can have There are at least about 6,000 optical fiber, or at least about 10,000 or at least about 10,000 5 or at least about 30,000 optical fiber or more. In certain embodiments, optical image fibers can be 6,000 6 hundred fibre bundles or 10,000 fibre bundles.

Similar to embodiment described elsewhere herein, Fig. 6 A- Fig. 6 C illustrates the elongated of tissue visualization gasifying device 1300 Main body and the embodiment of internal part.In this concrete in figure, the shell removing handle is with the inside of more preferable finder.Some In embodiment, tissue visualization gasifying device includes elongate body 1302, illumination component 1304, and light shell outer cover 1306, outside near-end lens Shell 1310, lasso 1314, revolving nosepiece 1312, and distal lens 1316.

Fig. 6 B illustrates the top view of the tissue visualization gasifying device 1300 of Fig. 6 A, and Fig. 6 C illustrates side view.The portion of these in figures Part is similar to the part shown in Fig. 6 A, but in 6B, visualization aggregation is designated as 1318.Visualization aggregation and periphery Part can see more details in the figure 7.

Fig. 7 illustrates the sectional view of the visualization aggregation embodiment of Fig. 6 C.In certain embodiments, visualize aggregation 1318 can include visible sensor 1320, such as this part or those visualizations describing elsewhere in illustrating herein Sensor.In certain embodiments, visible sensor can this part or describe elsewhere in this paper description Cmos sensor.

In certain embodiments, visualization aggregation can include the first lens 1322, and optical aperture 1324 and second is saturating Mirror 1326.In certain embodiments, this aperture can have an at least about 0.1mm, at least about 0.3mm, at least about 0.5mm or big Diameter in 0.5mm.Preferably, this aperture can be about 0.222mm.In order to support lens, visualization aggregation can include The near-end lens case of as described before, wherein, near-end lens case can be used for for lens 1320 and lens 1326 being fixed on conjunction Suitable position and direction.Visualization aggregation can also include image guide, and this image guide is similar to describing before The image guide related to Fig. 5.

As described in Fig. 1 and Fig. 8 A, one of the integrated and visualized device of the present invention as a result, visualization device 4 around in Heart longitudinal axis 1404 rotate and will cause clinician in the display (video screen of such as Fig. 1 with the expansion realizing visual field simultaneously The image 1501 of curtain 19 or Fig. 8 A) on the above-below direction seen significantly rotate.Therefore, it is desirable to can compensate so that patient Reference direction (for example upwards) always occurs from the top of screen 19, and unrelated with the direction of rotation of visualization device 4, for example, scheme In 8B shown in image 1503.

Can be above-mentioned interior to realize by including one or more sensor of being carried by visualization device 4 or switch Hold, this sensor and switch can produce the signal representing visible sensor 1132 direction of rotation.Signal through wired or Wireless protocols are transferred to controller 6 in the process of screen 19 or other display epigraph direction of rotation and correction, from And stablize image.

Suitable sensor can include simply tilting or direction sensor (such as mercoid switch), or being capable of phase Absolute reference direction (for example upper and lower) is determined to the other system of direction of rotation.Or, direction of rotation image correction system The 3 axle accelerometers with interlock circuit can be included, for example, utilize the little acceleration that MEMS (microelectromechanical systems) technology manufactures Meter, it determines the amount of acceleration using capacitance measurement, can from the Freescale Semiconductor of the Jane Austen positioned at Dezhou with Other companies obtain.

Replacement as accelerometer or increase to accelerometer, visualization device can carry gyroscope, such as three axle tops Spiral shell instrument.The output of gyroscope can be the rate of change of roll angle, the angle of pitch and deflection angle, and the rotation speed being provided by gyroscope Rate measurement can in conjunction with the measurement of accelerometer to provide the complete six degree of freedom description of the motion of sensor 1132 and position, although This description may not be necessary for simple correction direction of rotation.Can arrange on handle or controller 6 control it is allowed to Clinician select they like what reference direction (for example, above patient, below patient, real either above or below etc. Deng, or the actual sensor visual field makes the image on screen with sensor rotation) occur in the top of screen, and do not consider Sensor orientation.In some embodiments it is possible to labelling (such as arrow or line) is projected on image to further determine that Different orientation and/or direction.

In certain embodiments, optics hypotube can be encapsulated in heat-shrink tube.For example, description describes elsewhere Outer tubular main body can be manufactured by heat-sensitive material.Therefore, the elongate body describing elsewhere for manufacturing specification, optics Hypotube and miscellaneous part can extend and have the outer tubular main body of oversized dimensions and extend, afterwards this outer tubular main body pass through heat, Ultraviolet light, chemistry or other modes are retracted to the diameter of optics hypotube.As a comparison, in traditional endoscope and description its He optics is contained in rigid stainless steel tube some endoscopies of local description.However, optics is contained in not May need in rust steel pipe by many optical fiber and lighting fiber be compressed to internal diameter closely and after-applied alite paste (example As epoxy resin).This difficult treatment and costliness.

Fig. 9 A- Fig. 9 D is shown similar to the embodiment of the visualization device of visualization device in Fig. 1-Fig. 7.Fig. 9 A- Fig. 9 D Visualization device include at least one mirror to change direction of observation and the visual field of visualization device.Fig. 9 A illustrates may be inserted into The reflection plug 1600 of tubular body (for example related to Fig. 1-Fig. 3 B above described tubular main body) far-end.This plug can include mirror Face 1602, it for example, provides the direction of observation away from 30 degree of plug axis with special angle 1604 reflected image.In some enforcements In example, this angle can be much smaller, such as between 0-15 degree.In other embodiments, this angle can be from 15-45 degree model In enclosing.In certain embodiments, this angle can be at least 45 degree, at least 60 degree, at least 75 degree or at least 90 degree or more Greatly.As shown in fig. 9b and related to Fig. 9 A described above, plug 1600 may be inserted into tubular body 1606 (similar to saying The tubular body that bright book describes elsewhere) end.In an embodiment, plug may be embodied in description and describes elsewhere Any visualization device in.In certain embodiments, plug can be sharp to allow plug to penetrate tissue.

Fig. 9 C- Fig. 9 D illustrates the embodiment of the outer tubular main body of Fig. 9 B including window 1608.This window allows light from mirror Face 1602 is reflected and is guided along tubular body 1606, thus by window by the image of retrievable visual field along elongate body Transmission.This image can be transmitted along (for example description describes elsewhere) optics hypotube and/or image guide. Can be using miscellaneous part (such as illumination component) so that light be gone out by guiding along minute surface and from window, thus illuminating surrounding Tissue.In an embodiment, window can allow to extend forward and the visual field 1610 above tubular body far-end.According to minute surface Angle and direction, the amplitude of visual field can be between about 45 ° and 120 °, such as between about 55 ° and 85 °.Implement a kind of In mode, angle can be about 70 °.

In an embodiment, the visualization device in Fig. 9 A- Fig. 9 D can be manufactured by multiple devices.For example, it is possible to expect Angle cutting and milling (mill)/polishing tubular reflector material (for example represented by reflection plug 1600) are to produce minute surface 1602.This plug with minute surface can be supplied to the tubular body (pipe of such as Fig. 9 B- Fig. 9 D with cutting window 1608 Shape main body) opening 1606, and be soldered to tubular body.Once minute surface is properly positioned in tubular body, then permissible Cutting/milling tubular body and reflection plug are to produce the tip 1612 for example shown in Fig. 9 D simultaneously.

In an embodiment, desired direction of observation can be realized by prism is positioned at elongate body far-end.This rib Mirror can provide such as description disclosed direction of observation elsewhere, for example：There is provided and become 30 degree with respect to elongate body axis Direction of observation.In certain embodiments, this angle can be much smaller, such as between 0-15 degree.In a further embodiment, This angle can be in the range of 15-45 degree.In certain embodiments, this angle can be at least 45 degree, at least 60 degree, at least 75 Degree or at least 90 degree or bigger.

In certain embodiments, elongate body can be non-circular shape.For example, elongate body global shape can be Avette or oval.In certain embodiments, the far-end of only elongate body is oval and the remainder of elongate body It is circular.Oval elongate body beneficially allows for the exceptional space for deflection far-end.In certain embodiments, oval Major axis be about 1.1 times of short axle.In certain embodiments, major axis be at least 1.2 times of short axle, 1.3 times, 1.5 times, 1.75 Times, 2 times, 3 times, 4 times, 5 times or be more than 5 times.

In a particular embodiment, the far-end of elongate body can be manufactured by elastomeric material to allow far-end curved in far-end Bent.In addition, the leg portion of far-end can very short it is allowed to leg portion is maintained in the range of elongate body external boundary.

In certain embodiments, the far-end of elongate body can rotate with respect to optics hypotube.For example, sharp far-end Point can be below optics hypotube, in optics hypotube over top, or on the side of optics hypotube.In some realities Apply in example, optics hypotube can work as protective cover to prevent sharp remote point infringement surrounding's group in any direction Knit.In certain embodiments, optics hypotube can include protective cover at remote point, and this protective cover works with around protecting Tissue is not affected by the sharp distal of elongate body.Once optics hypotube rotates, then move from the sharp distal of elongate body Except protective cover it is allowed to be further penetrated through tissue.

Should be understood to be applied in conjunction with the feature of specific aspect, embodiment or example description, material, feature and group Book sections or any other aspect, embodiment or the example that describe elsewhere are described, except not both is incompatible.This theory All features disclosed in bright book (including any appended claim, summary and accompanying drawing), and/or disclosed any method or All steps of person's process can be combined into any combinations, except at least some mutually exclusive institute of this feature and/or step Combination.Protection domain is not limited to the details of any of above embodiment.Protection domain extends to this specification and (includes any institute Attached claim, summary and accompanying drawing) disclosed in any novel feature of feature or any novel combination, or Any novel step of disclosed any method or process steps or any novel combination.

While certain embodiments have been described, but these embodiments are assumed only by the mode of example, and not It is to limit protection domain.In fact, the method and system of this part or the novelty describing elsewhere can in description To be presented as various other forms.Furthermore, it is possible to making the method for this part in this specification or other parts description and being Omissions, substitutions and variations in system form.It will be appreciated by those skilled in the art that in certain embodiments, described and/or open During the actual step adopting can be to that indicated in the drawings those processes different.According to embodiment, above-mentioned one can be removed A little steps, can increase other steps.And, the feature of particular embodiments disclosed above and attribute can be in different modes In conjunction with to form extra embodiment, all embodiments fall within the scope of the disclosure.

Although the disclosure includes some embodiments, example and application, skilled artisan would appreciate that the disclosure Exceed specifically disclosed embodiment and extend to the use of other alternative embodiments and/or these embodiments and obvious change and Equivalent, including the embodiment not providing this part or all features proposing elsewhere and advantage in description.Therefore, originally Scope of disclosure be not intended to by this part in description or elsewhere in specifically disclosing of preferred embodiment limited, and And present or claims of afterwards presenting limited by this part in this specification or elsewhere.

Claims

1. a kind of aseptic, integrated, expendable disposable tissue visualization gasifying device, it includes：

Handle, it includes visible sensor；

Watch-dog, it is configured to display image；

Elongate body, it extends between the proximal and distal ends along longitudinal axis, and described close end is connected to described handle, and Described far-end includes the tip of lateral drift,

Elongated optical element, it extends through described elongate body, and described optical element is had far-end and passed with described visualization The near-end of sensor optical communication；

Controller on described handle, it is used for axially moving described elongated master between proximal location and remote location Body, in described proximal point, the proximal lateral of the described most advanced and sophisticated far-end in described optical element, in described remote location, institute State the distal side of the most advanced and sophisticated far-end in described optical element；

2. tissue visualization gasifying device according to claim 1, wherein, described most advanced and sophisticated transversal displacement is described elongated master The 50% of the external diameter of body.

3. tissue visualization gasifying device according to claim 1, wherein, described observation axis becomes 15 degree with described longitudinal axis Angle.

4. tissue visualization gasifying device according to claim 1, wherein, described elongated optical element also includes visual field, described Visual field includes the visual field forward along described longitudinal axis.

5. tissue visualization gasifying device according to claim 1, wherein, described visible sensor is wireless with described watch-dog Ground communication.

6. tissue visualization gasifying device according to claim 1, wherein, described handle includes shell shaped.

7. tissue visualization gasifying device according to claim 1, wherein, described far-end is by axially movable control line Lateral drift.

8. tissue visualization gasifying device according to claim 1, wherein, described elongate body includes being configured to antibiotic medicine is defeated Deliver to the chamber of internal tissue location.

9. tissue visualization gasifying device according to claim 1, also includes turn-sensitive device, and described turn-sensitive device is configured to Determine the direction of rotation of described visualization device.

10. tissue visualization gasifying device according to claim 9, wherein, described turn-sensitive device is communicated with described watch-dog With rotating image so that patient's reference direction is always occurred from the top of screen.

11. tissue visualization gasifying devices according to claim 1, wherein, described elongate body includes outer tubular main body, its In, described outer tubular main body is manufactured by thermo-sensitive material.

A kind of 12. methods manufacturing tissue visualization gasifying device, it comprises the following steps：

With desired angle cutting reflecting material thus exposing angled surface；

Angled surface described in milling is reflected image until described angled surface structure；

Described tubular reflector material is inserted tubular body, wherein said tubular body includes window；And